BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1085489 · Received August 1, 2008

    Report

    Report Number
    1056600-2008-00248
    Event Type
    Malfunction
    Date Received
    August 1, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 31, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. A OCD FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND DETERMINED THE PROBE WAS BENT AS A RESULT OF A DAMAGED FAG BEARING. REPLACEMENT OF THE APPROPRIATE COMPONENT HAS RETURNED THE INSTRUMENT TO EXPECTED OPERATION. THIS CUSTOMER HAS NO LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THE INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROBE OF THE ORTHO PROVUE ANALYZER DRIPPED FLUID ON TOP OF THE GEL CARD FOIL. NO ERRONEOUS RESULTS WERE REPORTED. PROBE DRIP MAY LEAD TO DILUTION OF SAMPLE / REAGENT, CARRY OVER AND / OR CROSS CONTAMINATION AND ERRONEOUS RESULTS WHICH COULD LEAD TO TRANSFUSION OF INCOMPATABLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1